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  • Moderna delays norovirus vaccine readout, cites insufficient infections
    Moderna announced that its norovirus vaccine trial will not yield efficacy data this season because infection rates were lower than expected. The company said it will open an additional trial coho…
    Endpoints · 11d agoNegative readoutNeutral↗ source
  • Apnimed secures $192 million IPO to fund sleep-apnea drug program targeting 2027 launch
    Apnimed, a biotech focused on sleep apnea, announced it raised $192 million through an initial public offering. The capital will be used to advance its lead drug candidate, with plans to begin a l…
    Endpoints · 11d agoDealPositive↗ source
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  • FDA announces reorganization and CTAGTAC votes on Duchenne muscular dystrophy and melanoma therapies
    The FDA disclosed a major internal reorganization aimed at streamlining its operations and improving efficiency across its divisions. The agency’s Cellular, Tissue, and Gene Therapies Advisory Com…
    raps · 11d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on container closure and device components for biosimilar combination products
    The FDA issued draft guidance aimed at helping sponsors develop container closure systems and device constituents for biosimilar and interchangeable biosimilar combination products. The guidance f…
    raps · 11d agoRegulatoryNeutral↗ source
  • Ionis veteran scientist Frank Bennett to retire in 2027 as Recursion appoints its first AI chief
    Ionis announced that Frank Bennett, who joined the company as a founding scientist in 1989 and later became chief scientific officer, will retire in February 2027 after a 37-year career. Bennett’s…
    Endpoints · 11d agoNeutral↗ source
  • Lidl US expands recall of Eridanous shortbread cookies over undeclared wheat, soy, milk, egg and coconut allergens
    Lidl US announced it is widening a recall that began on July 24, 2026 to cover all units of its Eridanous Shortbread Cookies that feature foreign-language packaging. The affected items include the…
    fda recalls · 11d agoRegulatoryNeutral↗ source
  • AtaiBeckley secured co-development and royalty offers before $2.8 B Lilly acquisition
    AtaiBeckley, a psychedelic biotech, received co-development and royalty proposals prior to finalizing a $2.8 B acquisition by Eli Lilly. Details were disclosed in an SEC filing that outlined the s…
    Endpoints · 12d agoDealNeutral↗ source
  • Sanofi books over €1 billion impairment after ending eczema drug and halting two immunology programs
    Sanofi disclosed that it will record more than €1.03 billion in impairment charges for the second quarter. The bulk of the charge stems from the decision to terminate development of an eczema trea…
    Endpoints · 12d agoNegative↗ source
  • Pfizer reports Phase 3 success for Litfulo in vitiligo trials; Braveheart and Attovia target $275M and $182M IPOs
    Pfizer announced that its experimental drug Litfulo achieved Phase 3 success in two separate studies targeting active and stable nonsegmental vitiligo, an autoimmune condition that causes loss of s…
    Endpoints · 12d agoPositive readoutPositive↗ source
  • Johnson & Johnson prepares $2.58 billion option to acquire Sail Biomedicines, expanding in-vivo CAR-T portfolio
    Johnson & Johnson announced a $2.58 billion option agreement to purchase Sail Biomedicines, a Flagship Pioneering‑backed biotech focused on in‑vivo CAR‑T therapies. The deal includes an upfront pa…
    Endpoints · 12d agoDealNeutral↗ source
  • Trump administration delays start of first pharma tariff wave originally set for July 31
    President Donald Trump's administration had scheduled the first set of pharmaceutical tariffs to begin on July 31, but the rollout has been postponed. A White House official said the implementation…
    Endpoints · 12d agoRegulatoryNeutral↗ source
  • UCB shares dip as investors worry forecast may be too optimistic despite Bimzelx sales beat
    UCB reported that sales of its lead drug Bimzelx exceeded analysts' expectations for the quarter. However, the company also gave a full-year revenue outlook that some investors view as overly opti…
    Endpoints · 12d agoEarningsNegative↗ source
  • Sanofi CEO Garijo outlines R&D overhaul, M&A push and China focus to counter patent cliff
    Garijo, three months into her tenure as Sanofi chief executive, shared her strategy for the company’s next phase of growth. She said the firm will conduct a thorough cleanup of its research and de…
    Endpoints · 12d agoPositive↗ source
  • Included Health to acquire Firefly Health, signaling push into alternative health plans
    Included Health announced it will acquire Firefly Health, a move aimed at expanding its presence in the emerging alternative health plan market. The acquisition reflects the company's belief that…
    Endpoints · 12d agoDealPositive↗ source
  • Ipsen says €2 billion cash reserves give it firepower for more M&A
    Ipsen's CFO Aymeric Le Chatelier said the company ended June with €2 billion in cash, which it describes as "firepower" for acquisitions. The cash position gives the French biotech firm flexibilit…
    Endpoints · 12d agoDealPositive↗ source
  • Alnylam lowers Amvuttra sales outlook amid waning demand, shares slide
    Alnylam released its second‑quarter earnings, highlighting a challenging year for the biotech firm. The report showed continued pressure on its product portfolio. The company cut its full‑year sal…
    Endpoints · 12d agoEarningsNegative↗ source
  • GSK to invest up to $110 million in expanded AI drug-discovery partnership with Relation Therapeutics
    GSK announced it will pay Relation Therapeutics up to $110 million to broaden their existing collaboration that uses artificial‑intelligence models to identify new drug candidates. The expanded ag…
    Endpoints · 12d agoDealPositive↗ source
  • FDA releases FY 2027 user fee rates for prescription, generic, biosimilar, device and over the counter programs
    The U.S. Food and Drug Administration has published its user fee schedule for fiscal year 2027. The rates cover prescription drugs, generic drugs, biosimilars, medical devices and over the counter…
    raps · 12d agoRegulatoryNeutral↗ source
  • FDA releases updated guidances for injectable peptide drugs and announces FY 2027 user fee rates
    The FDA has updated 17 draft product-specific guidances aimed at helping sponsors prepare abbreviated new drug applications for injectable peptide products. The guidances cover peptide therapies u…
    raps · 12d agoRegulatoryNeutral↗ source
  • Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 Years
    A new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…
    raps · 12d agoNegative↗ source
  • FDA releases FY 2027 user fee rates and updates guidance for injectable peptide ANDAs
    The U.S. Food and Drug Administration has published its user fee rates for fiscal year 2027, covering prescription drugs, generics, biosimilars, medical devices and over‑the‑counter products. The r…
    raps · 12d agoRegulatoryNeutral↗ source
  • Regeneron and Sanofi explore expanded partnership for Dupixent follow-on candidates
    Regeneron and Sanofi said they are in early discussions about expanding their collaboration beyond the existing Dupixent partnership. The companies indicated the potential scope could include deve…
    Endpoints · 12d agoDealPositive↗ source
  • Replimune argues its oncolytic virus plus checkpoint inhibitor benefits advanced melanoma patients at FDA advisory meeting
    Replimune presented data from its pivotal advanced melanoma trial to an FDA advisory committee. The company defended the trial design and results, emphasizing the added benefit of its oncolytic vi…
    Endpoints · 12d agoRegulatoryNeutral↗ source
  • EFPIA urges EU lawmakers to further cut clinical trial approval timelines under Biotech Act
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked EU legislators to go beyond the modest reductions in clinical trial approval times that are currently being c…
    raps · 12d agoRegulatoryNeutral↗ source
  • Takeda, Regeneron, Sanofi and Bristol Myers Squibb announce pipeline cuts in quarterly updates
    Takeda, Regeneron, Sanofi and Bristol Myers Squibb disclosed that they are trimming several drug development programs as part of their recent earnings releases. The cuts affect a mix of early‑stage…
    Endpoints · 12d agoNeutral↗ source